Product Risk Manager - Product Management & PPM Professional
Bengaluru (Bangalore Urban) Design / Civil engineering / Industrial engineering
Job description
Digitalization disrupts healthcare while boosting the speed and possibilities of today's and tomorrow's medical care. Siemens Healthineers - Digital Services offers the whole spectrum of digital health with Digital Ecosystem & Platforms , Integrated Decision Support and Pop Health Management . This will increase the value of our customer’s core processes by turning data into information that provides new insight into healthcare’s most challenging questions.
SHS TI DC IND SV is a key partner for Digital Services in developing digital products.
What are my responsibilities?
The Product Risk Manager of Integrated Decision Support is responsible for(but not limited to) :
· Identification and evaluation of risks which may occur to patients, operating personal or the device itself
· Documentation of risk evaluation results
· Definition of risk mitigations in collaboration with Product Definition and Architects
· Planning and execution of risk management activities with Project managers
· Control of implementation of the risk mitigations and appropriate evidence as required by DS Product RIsk Management process
· Responsible author of several documents: Risk Analysis, Risk Management Plan, Risk Management Report
· Mandatory Reviewer of various process- and product documents
· Collection and systematic review of information about the product (incl. similar products) in the production and the post-production phase
· Representation of the risk management in Audits, Assessments, ...
· Contribution to continuous improvement of Risk Management Process
Internal contacts
Regulatory Affairs & Quality Management & Designated Complaint Unit (DCU); Project and Product Management; Project Steering Group (PSG); SW Development/Test; Technical Documentation; Supplier Management
External contacts:
Risk Manager of other business units; Customer; Supplier; Auditors and assessors
Desired Qualification:
Qualification: B.E. / B.Tech / MCA/ M. Tech/ MSc (Computer Science)
Knowledge and Experience:
• 7 – 10 years of experience in Software Development / R&D activities
• Advanced knowledge about the medical device and its operation/use in customer environment
• Experience in Quality management and/or Regulatory Affairs recommended
• Hands-on experience (participation) in risk analysis activities
• At least 2 years experience in playing leadership roles (e.g. team lead, project lead etc.)
• Exposure to TFS is preferred
• Sound knowledge of software engineering processes is mandatory
General/Soft Skill requirements:
• Ability to learn and work independently
• Strong Analytical and Problem Solving Skills
• Able to make decisions; Result oriented
• Assertiveness and excellent communication skills
• Experience of working in geographically distributed teams.